The regulation of medical drugs and devices involves competing goals of assuring safety and efficacy while providing rapid movement of innovative ther...

Every five years, top officials of the Food and Drug Administration go behind closed doors to negotiate the terms of its core budget — about $3 billio...

The Food and Drug Administration (FDA) requires that medical device manufacturers establish and follow quality systems to help ensure products consist...

When managing research in Industry, there is a “how to” guide for basic Research Scientists in Industry: Step 1: Your boss tells you to do a study. Yo...

The way research is being funded is also different between Academia and Industry. In Academia, you apply for a grant - you write a very large documen...

When it comes to the valuing of research in making medical devices in academia, they do it for the love of it, "Neat-o!", they believe they are helpin...

Medical device manufacturers regulated by the FDA, EU, or any international regulatory agency must implement a quality management system for their med...

Medical device product and project risk management can rarely exist without the other. This becomes apparent when you are responsible for the project ...

Teamwork is essential in the Medical Device Development, Life Sciences and Biotech Industries, and it is the glue that ties everything together and ge...

Due to the occurrence of a global virus pandemic during the past few years, changes in where and how we work have dramatically occurred. Hybrid-style...

The graduate program at the New Jersey Institute of Technology should contain a better ratio of academic to practical courses, I believe the ratio sho...

What is the best career choice after finishing your postgraduate degree – ‘industry’ or ‘academia?'” It is really important to understand the differe...